The European Parliament has approved the new measures to ensure all clinical trial data is published to boost drug trial transparency.
Members of the European Parliament (MEPs) have voted overwhelmingly in support of the new EU Clinical Trials Regulation, forcing researchers to publish all their clinical trial data or face fines in a bid to ensure greater transparency across the Continent.
Under the new law, which is likely to take effect by 2016, all European clinical trial results will have to made publicly available on an online database once a decision on marketing authorisation has been made, even if the results are negative.
MEP Glenis Willmott said the new regulation would “make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe.”
The law will also smooth the process of cross-border trials, said Willmott, offering “hope to the millions of people in Europe suffering from rare diseases”.
“There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases,” she explained.
In a statement released in response to the law approval, European pharma body EFPIA said it “welcomes the legislation’s approach to transparency” and hoped the changes would “foster a more harmonised approach to clinical trials in the EU”.